da ®
NICE recommends Saxenda ®
( liraglutide injection 3 mg ) as a cost-effective use of NHS resources 1
NICE recommends Saxenda ® ( liraglutide 3 mg ) as a cost-effective treatment for
use in the NHS for adults with a BMI of at least 35 kg / m 2 , non-diabetic hyperglycaemia
, and a high risk of cardiovascular disease alongside a reduced-calorie diet and increased physical activity 1 * Saxenda ® ( liraglutide 3 mg ) must be prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service 1
‘ There is a high clinical need for other pharmacological options ’, as stated by NICE Appraisal Committee clinical experts 1
* The body mass index ( BMI ) threshold should be adjusted accordingly for people from minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population . 1 Non-diabetic hyperglycaemia defined as a haemoglobin A1c level of 42 to 47 mmol / mol ( 6.0 to 6.4 %) or a fasting plasma glucose level of 5.5 to 6.9 mmol / L . High risk of cardiovascular disease based on risk factors such as hypertension and dyslipidaemia ( defined as a total cholesterol level of > 5 mmol / L , or systolic blood pressure of > 140 mmHg , or a high-density lipoprotein level of < 1.0 mmol / L for men and < 1.3 mmol / L for women ). 1
1 . NICE . Final appraisal document . Liraglutide for managing overweight and obesity . 2020 . Available at www . nice . org . uk . Access date : November 2020
Prescribing information
Please refer to the Saxenda ® summary of product characteristics for full information . Saxenda ® Liraglutide injection 3 mg . Saxenda ® 6 mg / mL solution for injection in a pre-filled pen . One pre-filled pen contains 18mg liraglutide in 3mL .
Indication : Saxenda ® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index ( BMI ) of ≥ 30 kg / m ² ( obesity ) or ≥ 27 kg / m ² to < 30 kg / m ² ( overweight ) in the presence of at least one weight-related comorbidity such as dysglycaemia ( pre-diabetes or type 2 diabetes mellitus ), hypertension , dyslipidaemia or obstructive sleep apnoea . Posology and administration : Saxenda ® is for once daily subcutaneous use only . Is administered once daily at any time , independent of meals . It is preferable that Saxenda ® is injected around the same time of the day . Recommended starting dose is 0.6 mg once daily . Dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one week intervals to improve gastro-intestinal ( GI ) tolerability . If escalation to the next dose step is not tolerated for two consecutive weeks , consider discontinuing treatment . Treatment with Saxenda ® should be discontinued after 12 weeks on the 3.0 mg / day dose if patients have not lost at least 5 % of their initial body weight . Daily doses higher than 3.0 mg are not recommended . No dose adjustment is required based on age but therapeutic experience in patients ≥75 years is limited and not recommended . No dose adjustment required for patients with mild or moderate renal impairment or mild or moderate hepatic impairment but it should be used with caution . Saxenda ® is not recommended for use in patients with severe renal impairment including end-stage renal disease , or severe hepatic impairment or children and adolescents below 18 years . Contraindications : Hypersensitivity to the active substance or to any of the excipients . Special warnings and precautions for use : There is no clinical experience in patients with congestive heart failure New York Heart Association ( NYHA ) class IV and Saxenda ® is not recommended for use in these patients . It is also not recommended in patients with eating disorders or treatment with medicinal products that may cause weight gain , as Saxenda ® for weight management was not investigated in subjects with mild or moderate hepatic impairment ; it should be used with caution in these patients . Use of Saxenda ® is not recommended in patients with inflammatory bowel disease and diabetic gastroparesis since it is associated with transient GI adverse reactions including nausea , diarrhoea and vomiting . Acute pancreatitis has been observed with the use of GLP-1 receptor agonists , patients should be informed of the characteristic symptoms . If pancreatitis is suspected , Saxenda ® should be discontinued . If acute pancreatitis is confirmed , Saxenda ® should not be restarted . In weight management clinical trials , a higher rate of cholelithiasis and cholecystitis was observed in patients on Saxenda ® than those on placebo , therefore patients should be informed of characteristic symptoms .
UK20SX00190 I Date of preparation : November 2020
Thyroid adverse events such as goitre have been reported in particular in patients with pre-existing thyroid disease . Saxenda ® should be used with caution in patients with thyroid disease . An increased risk in heart rate was observed in clinical trials . For patients who experience a clinically relevant sustained increase in resting heart rate , treatment with Saxenda ® should be discontinued . There is a risk of dehydration in relation to GI side effects associated with GLP-1 receptor agonists . Precautions should be taken to avoid fluid depletion . Patients with type 2 diabetes mellitus receiving Saxenda ® in combination with insulin and / or sulfonylurea may have an increased risk of hypoglycaemia . Fertility , pregnancy and lactation : Saxenda ® should not be used during pregnancy . If a patient wishes to become pregnant , or pregnancy occurs , treatment with Saxenda ® should be discontinued . It should not be used during breast-feeding . Undesirable effects : Very common ( ≥1 / 10 ); nausea , vomiting , diarrhoea , constipation . Common ( ≥1 / 100 to < 1 / 10 ); hypoglycaemia , insomnia , dizziness , dysgeusia , dry mouth , dyspepsia , gastritis , gastrooesophageal reflux disease , abdominal pain upper , flatulence , eructation , abdominal distension , cholelithiasis , injection site reactions , asthenia , fatigue , increased lipase , increased amylase . Uncommon ( ≥1 / 1,000 to < 1 / 100 ); dehydration , tachycardia , pancreatitis , cholecystitis , urticaria , malaise , delayed gastric emptying Rare ( ≥1 / 10,000 to < 1 / 1,000 ); anaphylactic reaction , acute renal failure , renal impairment . The Summary of Product Characteristics should be consulted for a full list of side effects . MA numbers and Basic NHS Price : 5 x 3 ml pre-filled pens EU / 1 / 15 / 992 / 003 , £ 196.20 . Legal category : POM . Full prescribing information can be obtained from : Novo Nordisk Limited , 3 City Place , Beehive Ring Road , Gatwick , West Sussex , RH6 0PA . Marketing Authorisation Holder : Novo Nordisk A / S , Novo Allé , DK-2880 Bagsværd , Denmark . Date last revised : December 2019
Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . Adverse events should also be reported to Novo Nordisk Limited ( Telephone Novo Nordisk Customer Care Centre 0845 6005055 ). Calls may be monitored for training purposes .
Saxenda ® is a trademark owned by Novo Nordisk A / S .